FDA Drug recall D-400-2014
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, M…
- FDA Drug
- Class III
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class III recall of Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, M… by Mutual Pharmaceutical, citing labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely de….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-400-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mutual Pharmaceutical |
| Distribution | US |
Product
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
Reason
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Identifiers
| code_info | lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-400-2014%22
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